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NCT ID: NCT04449874 Recruiting - Colorectal Cancer Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Start date: July 29, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

NCT ID: NCT04448184 Recruiting - Clinical trials for Hematologic Neoplasms

Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)

PATH
Start date: February 16, 2022
Phase: Phase 3
Study type: Interventional

It is hypothesized that a strategy using prophylactic oral and intravenous Tranexamic Acid (TXA) with therapeutic platelet transfusions (if required) is safe and more effective than prophylactic platelet transfusions in patients undergoing an autologous hematopoietic stem cell transplantation (ASCT).

NCT ID: NCT04446351 Recruiting - Neoplasms Clinical Trials

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors

Start date: June 25, 2020
Phase: Phase 1
Study type: Interventional

This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy (Arm D); and in combination with belrestotug (Arm E); and with GSK6097608 + belrestotug (Arm F) in Japanese and Chinese participants. The study may assess the PK/PD cohorts for Arm E and/or Arm F in participants outside of China and Japan. Additionally, dostarlimab will be given in combination with cobolimab in Japanese participants. Drug name mentioned as belrestotug, GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as belrestotug.

NCT ID: NCT04444440 Recruiting - Clinical trials for Postoperative Urinary Tract Infection

Antibiotic Prophylaxis for Bladder Botox

Start date: July 6, 2021
Phase: Phase 4
Study type: Interventional

Injection of Botox into the bladder is a common treatment for overactive bladder. Postoperative bladder infection is one of the more frequently reported complications of this procedure. Prophylactic antibiotics given at the time of bladder Botox for the reduction of postoperative bladder infection have not been well studied. The main goal of our study is to determine if prophylactic antibiotics at the time of bladder Botox injection for the treatment of overactive bladder in women reduces postoperative bladder infection. The investigators are proposing a study which will randomize participants into two groups - one receiving Ciprofloxacin and the other receiving placebo pills for three days following the procedure. The primary outcome evaluated will be the difference in postoperative bladder infection between the two groups. The investigators will also investigate differences in reported side effects between the two groups possibly related to antibiotic use. Follow-up will be over six weeks following the procedure.

NCT ID: NCT04442516 Recruiting - Cancer Clinical Trials

Cisplatin Induced Kidney Toxicity

ACCENT
Start date: August 12, 2020
Phase:
Study type: Observational

Cisplatin (CisP) is a chemotherapeutic agent used to treat head and neck and lung cancer in adults and over 15 different pediatric cancers. Despite its known toxicity, CisP is still widely used as a first line chemotherapy as it is so effective. Nephrotoxicity is one of the most common adverse effects of CisP, occurring in 20-50% of patients. It manifests as acute kidney injury (AKI) typically within the first few days of exposure and is associated with short and long-term morbidity. Furthermore, AKI diagnosis is only possible once kidney damage has progressed to functional impairment, when mitigation strategies are ineffective. Tests that could predict AKI risk pre-emptively or diagnose early-stage AKI before functional loss would be very impactful, affording opportunities for prevention or early intervention to mitigate CisP nephrotoxicity, reduce morbidity and improve health outcomes. The field of metabolomics seeks to identify patterns of small molecules (metabolites) involved in cell or tissue metabolism related to disease states, or patient factors like lifestyle and genetics. Plasma and urine are ideal for sampling the metabolome, which can identify at-risk patients and reveal disease-related changes earlier than existing diagnostic methods do. In CisP-treated children and adults from across Canada, we will identify urine and plasma metabolite profiles a) prior to CisP dosing that predict CisP AKI risk, and b) shortly after dosing to identify early-stage nephrotoxicity, before clinical signs of AKI are detectable. Our identified biomarkers will allow individualization of CisP treatment based on the level of nephrotoxicity risk and the design of trials to mitigate the progression and complications of CisP nephrotoxicity.

NCT ID: NCT04441203 Recruiting - Clinical trials for Chronic Heart Failure

Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes

SELFIe-HF
Start date: May 4, 2020
Phase: N/A
Study type: Interventional

To demonstrate that a virtual Heart Failure Clinic (HFC) based on patient self-management using Pulmonary Artery Pressure (PAP) monitoring is superior to usual care of HFC, leads to decreased: hospital admissions for heart failure (HF), emergency department consultation and/or unplanned intravenous heart failure therapy and cardiovascular death, compared to a regular HFC, has low device-related complications and is cost-effective, in New York Heart Association (NYHA) class III and II (requiring diuretics) patients.

NCT ID: NCT04440215 Recruiting - Telerehabilitation Clinical Trials

Optimizing Patient Adherence to Stroke Rehabilitation Treatment

Telestroke
Start date: July 10, 2020
Phase: N/A
Study type: Interventional

Stroke impacts nearly 400,000 Canadians annually. Three quarters of stroke survivors will live with minor to severe impairments or disabilities; which require rehabilitation care. Strong evidence supports beginning rehabilitation as soon as the patient's medical status has stabilized and continuing following discharge from acute care. Access to optimal services is hampered, however, by travel distances to access rehabilitation, the lack of opportunities for structured and formal interprofessional communication among service providers, and failures to engage the patient and family members in a structured decision making process. Moreover, adherence to rehabilitation treatments has been shown to be suboptimal. Many patients refuse their outpatient rehabilitation treatments outright or decrease the duration and/or frequency of their treatments over time. The aim of this proposed mixed methods pragmatic clinical trial is to evaluate an intervention that provides patients who have experienced stroke the opportunity to return home safely after their acute hospital stay, to encourage patient (and family) engagement in their rehabilitation care, and to overcome challenges of access to patient-centered interprofessional rehabilitation care. The proposed intervention will entail 220 patients (and family) to receive rehabilitation care through remote, live treatment sessions with an interdisciplinary group of clinicians (called telerehabilitation) versus standard of care (n = 110 patients). Five rehabilitation teams will be trained to develop rehabilitation treatment plans that engage the patient and family, while taking advantage of a telerehabilitation platform to engage the patient/family. Grounded in findings gathered through a Canadian Institute of Health Research (CIHR) funded pilot study, the primary study objective is to evaluate process, clinical outcomes and costs of telerehabilitation in comparison with usual care. Through qualitative interviews with patients and family as well as clinicians, a second objective of this pragmatic, controlled trial is to explore and describe contextual factors (both personal and environmental) that will help the delivery of care, and improve patient's outcomes while fully using technology to deliver stroke rehabilitation care. This study represents a unique, highly relevant opportunity to minimize both knowledge and practice gaps, while producing robust, indepth data on the factors related to the effectiveness of telerehabilitation.

NCT ID: NCT04439916 Recruiting - Clinical trials for Cytomegalovirus Infections

Breakthrough CMV Lung Transplant -Multicentre

Start date: January 25, 2021
Phase:
Study type: Observational

Cytomegalovirus (CMV) infection is the most common opportunistic infection in lung transplantation leading to direct and indirect effects that can result in life threatening complications. The risk of CMV infection is highest when the recipient of the transplant has never been in contact with CMV (negative immunity) and the donor had previous contact with CMV (positive immunity). This is called CMV mismatch. For these lung transplant patients 6 to 12 months of prophylaxis with an antiviral called Valganciclovir is recommended. This antiviral can cause side effects like bone marrow toxicity and decrease in immune cells which can result in temporarily having to stop the treatment. Starting and stopping the prophylaxis may result in the CMV becoming resistant to the medication. While taking the prophylaxis it is possible to have a breakthrough of the CMV, this is often due to the development of resistance to the antiviral. The purpose of this study is to learn more about the rate of CMV breakthrough while on prophylaxis after lung transplantation in patients who are CMV mismatch. The investigators will also look at the rates of negative side effects caused by antiviral prophylaxis in this population.

NCT ID: NCT04439513 Recruiting - Clinical trials for Radial Artery Injury

Dual Artery Compression vs. Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EASY-RAO)

EASY-RAO
Start date: June 18, 2020
Phase: N/A
Study type: Interventional

This study aims to demonstrate the superiority in clinical performances of a dual artery compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device (HemoSTOP).

NCT ID: NCT04438070 Recruiting - COVID-19 Clinical Trials

COVID Screening Strategies in Homeless Shelters

Start date: April 10, 2020
Phase: N/A
Study type: Interventional

Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate.